A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Fluconazole

Criteria

Inclusion Criteria:

1. Females ≥18 and ≤75 years old;

2. Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;

3. Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;

4. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;

2. Presence of concomitant vulvovaginitis caused by other pathogens;

3. History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;

4. Moderate to severe hepatic and/or renal disorders;

5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;

6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;

7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;

8. Presence of significant laboratory abnormalities at screening;

9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;

10. Have planned surgeries or other medical procedures that may impact compliance with the protocol;

11. Known history of hypersensitivity or intolerance to azole antifungal drugs;

12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;

13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening;

14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;

15. Other conditions unsuitable for participation in the study per investigator's judgment.